federal_register: E4-3782
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| E4-3782 | Draft Guideline on Target Animal Safety: Examination of Live Veterinary Vaccines in Target Animals for Absence of Reversion to Virulence (VICH Topic GL41) | Notice | A draft guideline titled "Target Animal Safety: Examination of Live Veterinary Vaccines in Target Animals for Absence of Reversion to Virulence" has been developed by the International Cooperation on Harmonization of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). The draft guideline is intended to establish criteria and requirements for the conduct of studies that examine the potential for reversion to or increase in virulence of live veterinary vaccines in target animals. Because the draft guideline applies, in part, to veterinary biological products regulated by the Animal and Plant Health Inspection Service under the Virus-Serum-Toxin Act, we are requesting comments on its provisions so that we may include any relevant input on the draft in the Agency's comments to the VICH Steering Committee. | 2004-12-23 | 2004 | 12 | https://www.federalregister.gov/documents/2004/12/23/E4-3782/draft-guideline-on-target-animal-safety-examination-of-live-veterinary-vaccines-in-target-animals | https://www.govinfo.gov/content/pkg/FR-2004-12-23/pdf/E4-3782.pdf | Agriculture Department; Animal and Plant Health Inspection Service | 12,22 | A draft guideline titled "Target Animal Safety: Examination of Live Veterinary Vaccines in Target Animals for Absence of Reversion to Virulence" has been developed by the International Cooperation on Harmonization of Technical Requirements for... |